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EU MDR Compliance: A Checklist for Meeting Manufacturing, Safety and Performance Requirements

The FDAnews report EU MDR Compliance can help. Our editors have combed through the regulations, picking out the most minute compliance points and building them into a checklist of 200+ requirements you can use to confirm that you are satisfying all the EU mandates for device manufacturing.
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Accelerating Generic Drug Development: The FDA’s New Plan for Increasing Generic Competition

Accelerating Generic Drug Development explains the FDA’s new policy and shows how to navigate the new pathway to approval.

Events

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Feb 19

Medical Device Risk Management: Prepare for the Winds of Change

Feb 20

FDA’s Plan for Modernizing the 510(k) Pathway: What Regulatory, Quality & Compliance Professionals…

Feb 27

FDA Medical Device Compliance and Enforcement: Lessons from Last Year and Your Game Plan…

Mar 20

Medical Device Complaint Management: Escape the Labyrinth

Mar 22

REMS Regulatory Developments and Best Practices

Mar 26

Conducting Advanced Root Cause Analysis and CAPA Investigations

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FDA Issues Warning Over Unapproved Breast Implant Device

The FDA said that the surgeon has been advertising the unapproved device on his web site.
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FDA Recognizes Polish, Slovenian Inspections 

Regulators on both sides of the Atlantic are optimistic they’ll meet the deadline, which they hope will allow them to direct more inspection resources elsewhere.

GENVEC HALTS ENROLLMENT IN TRIAL FOR HEART DRUG

KEYWORDS Drug Pipeline Alert
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GenVec will stop enrolling patients in a Phase II trial testing the company's drug for treating severe coronary artery disease. The company will focus on its cancer-drug development instead, it announced.

Patients already enrolled in the Phase II study of the heart drug, called BioBypass, will complete follow-up and data will be collected and analyzed in accordance with the research agreement between GenVec and its collaborator, Cordis.